AXS Lift Intracranial Base Catheter

The AXS Lift Intracranial Base Catheter is a single-lumen, variable stiffness catheter with a hydrophilic coating designed to facilitate insertion and guidance of interventional devices into the peripheral and neurovasculature. It includes a radiopaque marker for visualization, a luer hub, and is supplied sterile and single-use only with a peel-away introducer sheath and rotating hemostasis valve.

The subject device is identical to the predicate device (K243593) in materials, design, indications, regulatory classification, and accessories. Both feature hydrophilic coatings, straight tips, 7F outer diameter, ethylene oxide sterilization, and 36-month shelf life. The subject device supports guidewire compatibility of 0.035–0.038 inches and effective lengths of 95, 105, 110, and 115 cm.

Testing was performed per EN ISO 10555-1 (catheter performance), EN ISO 14971 (risk management), ISO 10993-1 (biocompatibility), and EN ISO 10993-7 (ethylene oxide residuals). Verification and validation testing included tensile strength, torque strength, kink resistance, burst pressure, liquid leak testing, coating integrity, particulate testing, and simulated use with radial artery access.

The subject device is substantially equivalent to predicate K243593 because it shares identical indications for use, principle of operation, materials, design characteristics, and regulatory classification (Class II). Risk assessment determined no new questions of safety or effectiveness arise. All verification and validation testing demonstrated the device performs as intended with no material differences from the predicate.